Analytical Pharmacology Core Facility Shared Resource ABSTRACT The Analytical Pharmacology Core Facility (APCF) encourages and facilitates collaborative research between basic scientists and clinicians by providing comprehensive analytical and consultative services in a GLP-capable environment. The APCF assists with the design and implementation of pharmacokinetic, pharmacodynamic, and biomarker correlative studies for clinical and preclinical investigations of small molecules and biologic agents (e.g., antibodies, antisense oligonucleotides, vaccines, and cellular therapeutics). Primary services provided are: 1) quantitative assay development and sample analysis (LC-MS/MS, ICP-MS, GC/MS, HPLC, Luminex, ELISA, qPCR) of drugs, biomarkers, and related compounds; and 2) study design and expert analysis of pharmacokinetic and biomarker data. All major analytical equipment is consolidated into a contiguous suite of rooms in the Shapiro building. The most heavily utilized major equipment within the core are the LC-MS/MS instruments and the FLEXMAP 3D multiplex immunoassay platform. Mass spectrometry instrumentation includes a Micromass Quattro Ultima triple quad, a Waters Quattro Premier XE triple quad, an AB Sciex QTRAP 5500, an Agilent 6410, and a recently acquired Waters Xevo-TQXS. All systems provide state-of-the-art selectivity and sensitivity for detecting and quantifying analytes in complex biological matrices and are interfaced with HPLC front-end components. Additional key core equipment include an Agilent 8800 inductively-coupled plasma triple quadrupole mass spectrometer (ICP-MS) for determination of metals and metal-containing compounds and four complete HPLC systems. For analysis of biological agents, the Core has a FLEXMAP 3D Bioplex instrument for multiplex immunoassays, a Bio-Rad QX200 Droplet Digital PCR for absolute quantitation of gene expression, a FLUOstar OPTIMA multi-label plate reader for a wide range of high-throughput ELISA applications, and a Guava PCA-96 analytical cell analyzer. The core is directed by Dr. Timothy Synold, a Professor in the Department of Cancer Biology, with oversight by an interdisciplinary faculty Advisory Committee. Dr. Synold actively participates in most of the early drug development efforts within the Divisions of Hematology and Medical Oncology, which is reflected in the heavy usage by members of the DCT and HM Programs. User feedback is provided annually through user surveys. Since the last competitive renewal, the APCF contributed to 44 publications by CC members. Over the past five years, the APCF was used by a total of 74 unique investigators, including 56 CC members from all five Programs. Of the 56 CC members, 46 (82%) had peer-reviewed funding. During this period, 147 unique analytical methods were developed or re-initiated and 24,502 samples were analyzed. In addition, 4,632 clinical specimens were processed and 75 separate cancer clinical trials were supported by the core.